The new EMTALA regulations--introduction

This Introduction provides a broad overview of the new Emergency Medical Treatment and Labor Act (EMTALA) regulations and the changes they effected. The three Articles that follow discuss various aspects of the regulations in much greater detail. Health Lawyers Teleconference: EMTALA Update provides a commentary on the regulations from the perspective of representatives of the Centers for Medicare & Medicaid Services and the Department of Health and Human Services, followed by a critique of the regulations from a practitioner's standpoint. EMTALA: Dedicating an Emergency Department Near You analyzes the provisions of the regulations in detail and discusses their implications for hospitals and their counsel. Finally, The New EMTALA Regulations and the On-Call Physician Shortage: In Defense of the Regulations analyzes the on-call provisions of the regulations in light of the current shortage of on-call physicians.     

EMTALA: dedicating an emergency department near you

Congress enacted the Emergency Medical Treatment and Labor Act (EMTALA) in 1986 to prohibit patient dumping. Subsequent to its passage, however, issues concerning the application of EMTALA have vexed hospitals, patients, regulators, and courts. In an attempt to clarify these issues, the Centers for Medicare & Medicaid Services (CMS) recently promulgated new EMTALA regulations. This Article reviews the basic requirements of EMTALA and highlights the statutory definitions critical to its proper interpretation and application. The article then analyzes the impact of the new regulations, particularly in five major areas: where and when the statute applies, on-call physician requirements, hospital-owned ambulances, managed care, and bioterrorism. It concludes with a discussion of the implications of the new regulations for hospitals and their counsel.     

The new EMTALA regulations and the on-call physician shortage: in defense of the regulations

This Article examines the new Emergency Medical Treatment and Labor Act (EMTALA) regulations, focusing on the on-call provisions, in light of the practical realities of the on-call physician shortage. It provides an historical account of issues surrounding the delivery of emergency care by on-call physicians and the legal background of EMTALA insofar as it relates to on-call physicians. Ultimately, the author concludes that, although the current shortage of on-call physicians has caused hospitals to anticipate EMTALA liability and advocate for more specific regulations, a closer look reveals that hospitals' fears are overstated. As long as hospitals have proper procedures in place, the new regulations will not put them in violation of EMTALA.     

Call 911: psychiatry and the new Emergency Medical Treatment and Active Labor Act (EMTALA) regulations

The Emergency Medical Treatment and Active Labor Act (EMTALA), enacted in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act of 1985, aims to prevent "patient dumping" by requiring hospitals to screen and stabilize patients who come to an emergency room seeking medical attention. For many reasons, recovery under EMTALA is rare, especially when psychiatric treatment is called for. New regulations of EMTALA went into effect on November 10, 2003. These new regulations helpfully clarify the applicability of EMTALA. However, the bias against recovery in cases involving psychiatric emergencies is likely to remain.     

Opioid drugs in maintenance and detoxification treatment of opiate addiction; Substance Abuse and Mental Health Services Administration, HHS. Final rule

The Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration (SAMHSA) are issuing final regulations for the use of narcotic drugs in maintenance and detoxification treatment of opioid addiction. This final rule repeals the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and creates a new regulatory system based on an accreditation model. In addition, this final rule shifts administrative responsibility and oversight from FDA to SAMHSA. This rulemaking initiative follows a study by the Institute of Medicine (IOM) and reflects recommendations by the IOM and several other entities to improve opioid addiction treatment by allowing for increased medical judgment in treatment.     

Indian health--PHS. Proposed rule

The Department of Health and Human Services (HHS) is proposing to make technical amendments to Indian Health Service (IHS) grant regulations to make them conform to HHS regulations on grant administration, thereby eliminating duplication and conflict within the regulations.     

Projects grants for community health services; proposed rulemaking--Public Health Service. Notice of proposed rulemaking

The Assistant Secretary for Health with the approval of the Secretary of Health and Human Services proposes to revise the regulations governing the Community Health Centers grant program. The Health Services and Centers Amendments of 1978 made a number of changes in the statutory requirements governing the operation of the centers. The Amendments, among other things, change pharmacy services from supplemental to primary health services, establish priority for certain supplemental health services, provide an incentive for maximized collection of fees, permit conversion of certain centers from fee for service to prepaid operations, and change the governing board requirements or public centers. The proposed revisions are intended to revise the present regulations consistent with the revised statutory provisions.     

EMTALA: reaching beyond the emergency room to expand hospital liability

The Office of the Inspector General and private plaintiffs are vigorously pursuing EMTALA violations. These efforts are particularly troubling to hospitals, who face difficult statutory interpretation and application questions, especially in light of managed care reimbursement requirements. Two recent cases, one of them from the United States Supreme Court, expand hospital liability under EMTALA. This Article reviews current EMTALA standards and regulations, and analyzes how the recent decisions, in the absence of congressional action, are likely to impose substantial burdens upon hospitals.     

Project grants for migrant health; proposed rulemaking--Public Health Service. Notice of proposed rulemaking

The Assistant Secretary for Health with the approval of the Secretary of Health and Human Services proposes to revise the regulations governing the Migrant Health Centers grant program. The Health Services and Centers Amendments of 1978 made a number of changes in the statutory requirements governing the operation of the centers. The Amendments, among other things, change pharmacy services from supplemental to primary health services, make former migratory agricultural workers who are disabled eligible for services, establish priority for certain supplemental health services, provide an incentive for maximized collection of fees, permit conversion for certain centers from fee for service to prepaid operations and change the governing board requirements for public centers. The proposed revisions are intended to revise the present regulations consistent with the revised statutory provisions.     

Discontinuation of approval of modifications in notes, guaranteed under Title VI or VII of the Public Health Service Act, proposed to permit use of the notes as collateral for tax-exempt financings--PHS. Final rule

The Department of Health and Human Services (HHS) adds a new section to regulations for making and guaranteeing loans for construction and modernization of hospitals and medical facilities and to regulations for guaranteeing loans for the construction of teaching facilities for health professions personnel. Under these regulations HHS will not approve the modification of the terms of an existing loan guaranteed under Title VI or Title VII of the Public Health Service (PHS) Act if the modification would permit use of the guarantee (or guaranteed loan) as collateral for tax-exempt financing.     

Contract medical care; non-federal hospital payment rates--DVA and HHS. Final regulations

The Department of Health and Human Services (HHS) and the Department of Veterans Affairs (VA) have jointly amended VA's medical series of regulations to carry out provisions of Public Law 99-576, Veterans' Benefits Improvement and Health-Care Authorization Act of 1986. These regulations describe the payment methodology and amounts for non-Federal public and private hospital care provided at VA expense. Payment methodology and amounts will be determined by the Health Care Financing Administration (HCFA) PRICER.     

Specifications for medical examinations of underground coal miners. Final rule

This final rule modifies the Department of Health and Human Services (HHS) regulations for medical examinations of underground coal miners. Existing regulations established specifications for providing, interpreting, classifying, and submitting film-based roentgenograms (now commonly called chest radiographs or X-rays) of underground coal miners. The revised standards modify the requirements to permit the use of film-based radiography systems and add a parallel set of standards permitting the use of digital radiography systems. An additional amendment requires coal mine operators to provide the National Institute for Occupational Safety and Health (NIOSH) with employee rosters to assist the Coal Workers' Health Surveillance Program in improving participation by miners.     

Health and Human Services policy for protection of human subjects research--HHS. Final rule

The Department of Health and Human Services (HHS) is amending its Human Subjects Protection regulations to rescind the provision requiring prior review and advice from an Ethical Advisory Board for research applications and proposals involving in vitro fertilization (IVF) of human ova as a prerequisite to funding by HHS and its components. The provision was nullified by the National Institutes of Health Revitalization Act of 1993. The regulations are being amended to reflect this statutory nullification. Institutional Review Board (IRB) review and approval of applications and proposals involving in vitro fertilization (IVF) of human ova continues to be required in accordance with other provisions of the Human Subjects Protection regulations. Furthermore, the Secretary may still exercise the option of seeking advice from an Ethical Advisory Board on ethical issues, including IVF, raised by research applications and proposals.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, amends the regulations governing certificate of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The amendments accomplish two tasks: (1) To implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and (2) to reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Department's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations change the requirements for satisfactory certificate of need programs.     

Special report on patient care. HCFA finally issues patient-dumping regulations

EMTALA has always been an especially worrisome law for providers because its requirements are both sweeping and vague, with potentially drastic penalties for violations. The new regulations remove only some of the law's vagueness. As with previous EMTALA amendments, all United States hospitals, as well as emergency department physicians and other doctors who see patients in the emergency department, should carefully review their internal policies regarding patient ++ transfers in light of the new regulations. For example, hospitals must have an internal policy for following up on suspicious transfers, as failure to detect an inappropriate transfer can now potentially result in a Medicare decertification action. Also, hospitals with specialized services (e.g., burn units or shock-trauma units) should review their policies on receiving transfer patients in light of the greater specificity of the new regulations. Finally, because of the confusing new requirements regarding ambulance services, all hospitals should review their relationships with and policies regarding, ambulance services and ambulance diversion.     

Protection of human research subjects. Department of Health and Human Services (DHHS). Final rule

The Department of Health and Human Services (DHHS) is amending its human subjects protection regulations. These regulations provide additional protections for pregnant women and human fetuses involved in research and pertains to human in vitro fertilization. The rule continues the special protections for pregnant women and human fetuses that have existed since 1975. The rule enhances the opportunity for participation of pregnant women in research by promoting a policy of presumed inclusion, by permitting the pregnant woman to be the sole decision maker with regard to her participation in research, and by exempting from the regulations six categories of research. The rule also provides a mechanism for the Secretary of HHS to conduct or fund research not otherwise approvable after consultation with an expert panel and public review and comment.     

Availability of information and records to the public; fees for providing information and records; procedures and appeals--SSA. Notice of proposed rulemaking

The Social Security Administration (SSA) announces proposed changes in the fees it charges for providing records from its files and record related services. These proposed changes will conform SSA's fee schedule to that recently published by the Department of Health and Human Services (HHS). The proposed rules also implement the discretion given the Secretary of Health and Human Services by section 2207 of the Omnibus Budget Reconciliation Act of 1981 to charge the full cost of providing certain information and records. The proposed rules do not change SSA's longstanding policy of generally not charging an individual for information needed to assure that our records concerning her or him are correct. In preparing these amendments, we deleted from SSA's rules several provisions concerning Medicare information. The Health Care Financing Administration (HCFA) has published separate regulations governing the availability of Medicare information and records. We have also clarified the rules for handling requests for information about individuals under the Privacy Act and the Freedom of Information Act (FOIA) and incorporated HHS' recent rules on who has authority to release or deny records in this revised material.     

Technical revisions to conform to the Caregivers and Veterans Omnibus Health Services Act of 2010. Final rule

This final rule amends Department of Veterans Affairs (VA) medical regulations to incorporate statutory amendments. Certain statutes authorizing VA health care benefits were amended by the Caregivers and Veterans Omnibus Health Services Act of 2010. The statutory amendments affect enrollment in certain health care priority categories and exempt catastrophically disabled veterans from copayment requirements.     

American Health Lawyers Association: the year in review 2002-2003

Every year, the Practice Groups of the American Health Lawyers Association assemble a Year in Review summary of the leading developments in case law, legislation, and administrative actions affecting healthcare. This Article provides a comprehensive overview of these developments. The introduction presents a "Top Ten" list of the year's most noteworthy developments. The remainder of the Article is divided into fourteen topical areas, and offers a brief overview of issues in those areas. Overall, these various developments demonstrate society's efforts to balance accountability, efficiency, and affordability in the delivery of healthcare.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS. Notice of proposed rulemaking

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, proposes to amend the regulations governing certificates of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The proposed amendments would accomplish two tasks: (1) Implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35) and (2) reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Secretary's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth proposed changes to the requirements for satisfactory certificate of need programs. Interested persons are invited to submit written comments and recommendations concerning these proposed rules as well as suggestions for alternative methods of implementing any of the provisions of the amendments that affect the requirements for certificate of need programs.